Who we've worked with.

Cognigen has partnered with more than 40 global pharmaceutical and biotechnology companies, as well as with the World Health Organization, the Centers for Disease Control and Prevention, and the US Food and Drug Administration. In 2007, 25% of the drugs submitted to the FDA utilized population-based analyses performed by Cognigen.

How we work.

At Cognigen, we use a disciplined approach to model development and strategic thinking, coupled with highly collaborative client relationships, to consistently meet time, quality, and cost requirements for generating rigorous, scientifically valid results.

Our culture.

At Cognigen, we create a working environment that promotes continuous learning and encourages cross-functional team collaboration.

Our attention to detail.

Our experienced data management and programming team is trained in the nuances of pharmacokinetic and pharmacodynamic data, including the Standard for Exchange of Nonclinical Data (SEND) guidelines for animal toxicology studies.

The scientific PK/PD modeling group at Cognigen has extensive experience in challenging research and development scenarios across a wide range of therapeutic areas using a variety of biomarkers and endpoints.

How we think big picture.

At Cognigen, we recognize the downstream implications of translational medicine research and its applications across the lifecycle of development and commercialization.

We possess the strategic insight and experience required to look across the lifecycle of development within and across franchise platforms in order to interpret model-based assessments of comparators and design innovative proof of mechanism and proof of concept studies. We also integrate new knowledge about the pharmacology of compounds and competitors into the design of innovative pre-clinical and clinical study strategies.

Our commitment to technology.

Cognigen has invested more than $5 million over the past ten years in our IT infrastructure, including hardware and software installations and upgrades, security, data warehousing, and communication tools.

We recently introduced Version 3.2 of the PERSPECTIVE Hypertext Data Analysis Mapping software, which provides a visual interpretation of the scientist's analytical thought process and organizes the data, programs, output, and interpretation of analyses in a comprehensive, cohesive manner. Our Knowledge Portals allow global 24/7 communication, discussion, and collaboration of scientific researchers across the Internet using tools such as PERSPECTIVE Maps, discussion boards, web tours, white boards, and distance learning.

How we ensure quality.

Cognigen's Quality Management System has been subjected to 21 major sponsor audits over the last 5 years with no major findings. We are proud of our established reputation with regulatory agencies worldwide for the quality and comprehensiveness of our scientific rationale and deliverables, and we strive to advance the science and engineer systems for model-based drug development.

Our services.

Cognigen Corporation uses the tools of pharmacometrics, embedded in a highly developed enterprise infrastructure, to support decision-making at critical points in drug development. We provide comprehensive pharmacometric analysis and support services emphasizing pharmacokinetic and pharmacodynamic (PK/PD) analyses, statistical modeling, and clinical trial simulations focused on dose selection and justification.

How to contact us.

Harness the power of pharmacometrics.

Raise your hand if you wish there was a way to make drug development more efficient. Guess what? There is. It’s called model-based drug development, and it involves using quantitative analysis to better design protocols, determine dosage levels, and figure out other neat stuff that lead to successful regulatory filings. Once you see how incredible (and cost-effective) pharmacometrics can be, you’ll be hooked.